Xarelto is a popular anticoagulant medication that is widely prescribed. The makers behind the medication, Janssen Pharmaceuticals and Bayer, have been involved in litigation for several years. The majority of Xarelto lawsuits allege that patients were not appropriately warned of the health risks associated with taking Xarelto.
In March 2019, a major settlement was reached between the two pharmaceutical companies and the thousands of lawsuits involved in litigation.
What Is Xarelto And Is It Safe?
As an anticoagulant, Xarelto (rivaroxaban) is used to treat multiple health issues related to blood clots.
Xarelto is commonly prescribed for:
- reducing the risk of blood clots and stroke in patients with atrial fibrillation
- treating blood clots in the lungs (pulmonary embolism or PE)
- treating blood clots in the veins of the leg (deep vein thrombosis or DVT)
- reducing the risk of blood clots recurring after treatment for DVT or PE
- preventing blood clots in the lungs or legs following knee or hip replacement surgery
- lowering the risk of heart attack and stroke for patients with coronary artery disease
When Xarelto first hit the market, it was initially marketed for its convenience and safety. This contrasted with the more prominent anticoagulant medication at the time, warfarin, which came with health risks and required two doses each day. Xarelto, on the other hand, was hailed by researchers and health professionals for its safety and effectiveness as a single pill.
The FDA approved Xarelto for treating and preventing multiple conditions in 2011, and millions of people filled prescriptions for the drug. However, the safety of Xarelto was soon called into question because of a bleeding risk that had no antidote to stop the bleeding.
Xarelto Side Effects
Although this medication can be useful for patients dealing with certain conditions, many of the Xarelto lawsuits claimed that the dangerous side effect of gastrointestinal bleeding was too risky without an antidote, or an agent that could stop the bleeding.
In fact, any patient who took Xarelto before May 2018, when an antidote finally became available, was at a severe risk of uncontrollable bleeding from any injury that would normally clot if not for the medication.
It’s recommended by the FDA that you call your doctor if you experience any of the following Xarelto side effects:
- severe or uncontrollable bleeding
- pink or brown urine
- tar-like, bloody, or black stools
- bleeding from the gums
- arm or leg pain
- coughing up blood
- blood clots
- vomiting blood (or vomit that looks like coffee grounds)
- swelling or pain at wound sites
- dizziness, weakness, or headaches
Xarelto’s FDA Approval
Xarelto received FDA-approval in 2011. However, it was no easy task. The medical device the drug manufacturers used to test the bleeding risk was called into question by the FDA. The FDA warned the makers of both the device and Xarelto for understating the risk for bleeding.
The device was later recalled, but the FDA eventually announced that the device did not play a role in failing to detect the bleeding risk. The FDA declared Xarelto was safe and effective in 2016.
What To Do If You Take Xarelto
Doctors and health professionals urge patients on Xarelto to not stop taking the medication before consulting with their physician. The abrupt discontinuation of anticoagulants like Xarelto can result in severe health risks like stroke, heart failure, or death.
If you have taken Xarelto and suffered some kind of injury, consider reaching out to an attorney. Although many of the cases were resolved in the 2019 settlement, you may still qualify for a case if you took Xarelto before Andexxa (the antidote) hit the market in 2018.
What You Need To Know About Xarelto Lawsuits
Tens of thousands of people filed Xarelto lawsuits against drugmakers Janssen Pharmaceuticals (a Johnson & Johnson company) and Bayer. The lawsuits claimed that the drug was marketed as a safe blood thinner without warning consumers and patients about the dangerous side effects associated with the medication, including uncontrollable bleeding.
Bayer And Janssen Pharmaceuticals Settlement
After five years of Xarelto litigation, Bayer and Janssen Pharmaceuticals reached a settlement agreement in March, 2019. The settlement amount of $775 million will be split between the two companies, so each company will pay around $387.5 million. This settlement resolved the more than 25,000 pending Xarelto lawsuits against the two pharmaceutical companies.
The average compensation each plaintiff is entitled to breaks down to about $31,000. However, each case is individually assessed, so some plaintiffs may receive a larger payout than others.
Xarelto Pharmaceutical Companies And Liability
Neither Bayer nor Janssen Pharmaceuticals admitted liability in the settlement. The pharmaceutical giants continue to believe the legal claims over Xarelto were without merit. The settlement, according to Bayer, was not an admission of liability, but rather a way to avoid the costly distraction of continued litigation.
How The Xarelto Antidote Complicates Legal Claims
An antidote to stop the uncontrollable bleeding associated with Xarelto was approved by the FDA in May 2018. Once the antidote, which is sold under the brand name Andexxa, became available, Xarelto was considered safer because the bleeding could now be controlled.
The approval of the antidote affected legal claims because many of the claims focused on the irreversible bleeding effects of Xarelto. If you experienced an injury from taking Xarelto, but did so after the release of Andexxa, you’re unlikely to be eligible for a personal injury lawsuit.
Who Is Eligible To File A Xarelto Lawsuit?
Even though the antidote is currently available, if someone experienced uncontrollable bleeding or another severe health event before the 2018 release of Andexxa, then they may still have a case. However, the case must include a bleeding incident that involved hospitalization.
You may be eligible for a Xarelto lawsuit if:
- the statute of limitations in your state is still current
- you took Xarelto as directed for a prescription and suffered a severe bleeding event before Andexxa was available
- if a family member died from injuries associated with Xarelto
The Drugmakers Continue To Profit From Xarelto
Although Xarelto has been involved in litigation over the safety of the drug for years and years, Xarelto is still a popular medication and market shares continue to rise.
Janssen Pharmaceuticals and Bayer have seen extraordinary profits from marketing and selling Xarelto. Financial reports released in late 2018 suggest the anticoagulant medication earned the manufacturers almost $2 billion in that year alone.
Xarelto Lawsuit Damages
Although the companies are seeing massive profits, as a patient you may face high medical bills or other costs as a result of taking Xarelto. Treating bleeding injuries are costly, especially when you factor in follow-up visits.
However, filing a Xarelto lawsuit entitles you to collect damages for any loss or injury you suffered from taking the medication. If you win your case, you may be compensated for medical bills, lost wages, funeral expenses, and more.
Did Any Xarelto Lawsuits Go To Trial?
In total, six Xarelto lawsuits went to trial. As Bayer noted in their statement about the 2019 settlement, all six trials ruled in favor of the drugmakers. Because of these legal victories, the number of lawsuits have slowed down since 2017-2018. The March 2019 settlement also resolved the majority of pending Xarelto lawsuits.
Types Of Xarelto Lawsuits
The majority of Xarelto lawsuits claimed that people suffered internal bleeding as a result of taking the medication. Other injuries included brain bleeds, as well as wound leakage or infection after a knee or hip replacement surgery.
Lawsuits also claimed that the drugmakers never properly warned senior citizens about the increased risk of bleeding, as well as an increased risk for patients with gastrointestinal disorders.
Depending on the specific details of your case, you may file a:
- Xarelto personal injury lawsuit
- Xarelto wrongful death lawsuit
- Xarelto class action lawsuit
Xarelto Personal Injury Lawsuits
Personal injury lawsuits claim that the plaintiff was directly harmed or injured as a result of taking Xarelto. A personal injury lawsuit would be filed against the drug manufacturer for failing to warn patients about the risks associated with the anticoagulant.
To file a Xarelto personal injury lawsuit, you must have suffered the harm caused by the medication before the antidote (Andexxa) became available in May 2018.
Xarelto Wrongful Death Lawsuits
A Xarelto wrongful death lawsuit seeks to collect damages for losing a loved one or family member as the result of taking the medication. A wrongful death lawsuit is filed against the negligent parties, in this case Bayer and Janssen Pharmaceuticals, for failing to make patients aware of the risk associated with the medication that led to their death.
Xarelto Class Action Lawsuits
A Xarelto class action lawsuit, like the other lawsuits, claims that the drugmakers were aware of the risk of prolonged bleeding, but failed to warn health regulators and physicians. Class action lawsuits include multiple plaintiffs coming forward with a case against one or more defendants. These lawsuits have one plaintiff play an active role in litigation.
Class action lawsuits are limited in the amount of compensatory damages that can be awarded. A class action lawsuit is likely to only compensate patients for the money they spent on Xarelto. However, many of the Xarelto claims were not consolidated as a class action lawsuit, but as multidistrict litigation.
Xarelto Multidistrict Litigation
Over 25,000 Xarelto lawsuits were consolidated into multidistrict litigation (MDL) in Louisiana. MDL combines similar cases into one federal court. An additional 2,000 Xarelto lawsuits were filed in the Philadelphia Complex Litigation Center (CLC), which is a mass tort program.
MDL 2592 In RE: Xarelto (Rivaroxaban) Products Liability Litigation
In 2017, a federal judge oversaw three bellwether Xarelto trials. In MDL, a bellwether trial is considered a test trial that can influence the outcomes of any remaining cases. All three trials ruled in favor of the defendants, Bayer and Janssen Pharmaceuticals.
Here are some details about the three plaintiffs and their bellwether cases:
Bourdreaux’s case was the first to be tried and occured in April 2017. The 75-year-old plaintiff received a Xarelto prescription in 2014 to treat a heart condition. After taking the medication, he was hospitalized for gastrointestinal bleeding. In the end, the jury sided with the drugmakers, noting the plaintiff’s doctor had enough information to weigh the risks.
This plaintiff was a widower whose wife died in 2015 after suffering complications associated with Xarelto. This wrongful death claim was tried in June 2017, and Orr alleged that the prescribing doctors did not have enough information to appropriately weigh the benefits of the medication against the health risks. The jury also sided with the drugmakers in this case.
The third bellwether trial took place in August 2017. Mingo claimed that she suffered severe gastrointestinal bleeding after taking Xarelto to prevent a blood clot after surgery. Even though she only took Xarelto for a short time, the jury ruled in favor of the defendants.
Xarelto Trials In The Philadelphia Complex Litigation Center (CLC)
The other large group of consolidated MDL Xarelto lawsuits began in 2014. Over 1,900 cases were filed in the Pennsylvania state court that handled such litigation. The first of three bellwether cases for this group of lawsuits was tried in late 2017.
This first case involved Lynn Hartman, a woman who first took Xarelto to treat atrial fibrillation in 2013. After taking Xarelto for a year, she was hospitalized for bleeding complications. She was then taken off Xarelto.
Her lawsuit alleged the bleeding was the result of her Xarelto medication. Although the jury initially awarded Hartman $27.8 million, the judge reversed the ruling in 2018 because of an obscure issue involving the prescribing physician.
The other two bellwether cases tried in the CLC, which included plaintiffs Daniel Russell and Kevin Cooney, ruled in favor of the defendants.
Dangerous Drug And Xarelto Lawsuit Attorneys Serving The U.S.
Though much of the litigation surrounding Xarelto has been resolved, you may still have a case. This is especially true if you suffered harm from Xarelto before Andexxa was available. Even if you’re not sure, it can help to consult with a qualified attorney.
At Florin|Roebig, our experienced team of qualified dangerous drug and Xarelto lawsuit attorneys includes:
- Wil H. Florin, B.C.S.
- Tommy D. Roebig, B.C.S.
- Michael L. Walker, B.C.S.
- Chase P. Florin, B.C.S.
- Shaun M. Cummings
- Luca G. Esposito
- Chad K. Florin, M.B.A., LL.M.
- Nicholas S. Costantino
- Jordan A. Kolinski
- Matthew L. McMullen
- Michael A. Ossi, O.C.
- Lawrence J. Najem, O.C.
- Andrew M. Leone, O.C.
- Nollys R. Solarte, O.C.
- Brian R. Dettman, O.C.
Contact Florin|Roebig For Help Filing A Xarelto (Rivaroxaban) Claim Today
If you suffered from bleeding complications associated with Xarelto, or lost a loved one because of it, you may have the right to legal action. Although drugmakers Janssen Pharmaceuticals and Bayer settled thousands of cases in 2019, your Xarelto case may still qualify for litigation.
At Florin|Roebig, we offer free case evaluations to help you decide if moving forward is in your best interest. Our team of qualified attorneys will assess the merits of your case and help you figure out your next move. For more information, contact our offices today.